UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000025101
Receipt number R000028864
Scientific Title Changes in the number of accidental catheter removal through the early intervention by multidisciplinary team for patients with delirium
Date of disclosure of the study information 2016/12/01
Last modified on 2018/06/07 16:42:22

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Basic information

Public title

Changes in the number of accidental catheter removal through the early intervention by multidisciplinary team for patients with delirium

Acronym

Changes in the number of accidental catheter removal through the early intervention by multidisciplinary team for patients with delirium

Scientific Title

Changes in the number of accidental catheter removal through the early intervention by multidisciplinary team for patients with delirium

Scientific Title:Acronym

Changes in the number of accidental catheter removal through the early intervention by multidisciplinary team for patients with delirium

Region

Japan


Condition

Condition

delirium

Classification by specialty

Nursing

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The effectiveness of early intervention for patients with delirium

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Changes in the number of accidental catheter removal associated with occurrence of delirium

Key secondary outcomes

age, gender,
Day and time when accidental catheter removal happened,
Changes of the condition before and after accidental catheter removal, PS,
Drugs used for sleepless or restless Consultation to psychiatrist


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -but assessor(s) are blinded

Control

No treatment

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Prevention

Type of intervention

Maneuver

Interventions/Control_1

To build up the unified system of early intervention for patients with delirium

Interventions/Control_2

Usual care

Interventions/Control_3


Interventions/Control_4


Interventions/Control_5


Interventions/Control_6


Interventions/Control_7


Interventions/Control_8


Interventions/Control_9


Interventions/Control_10



Eligibility

Age-lower limit

65 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

1.admitted patients in emergency 2.patients who needed intravenous drip infusion
3. Patients who obtained informed consent for research

Key exclusion criteria

Patients who could obtain informed for research

Target sample size

200


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Sachiko Inoue

Organization

Uwajima City Hospital

Division name

Department of Nursing

Zip code


Address

1-1,Goten-machi,Uwajima

TEL

0895-25-1111

Email

s.inoue@uwajima-mh.jp


Public contact

Name of contact person

1st name
Middle name
Last name Sachiko Inoue

Organization

Uwajima City Hospital

Division name

Department of Nursing

Zip code


Address

1-1,Goten-machi,Uwajima

TEL

0895-25-1111

Homepage URL


Email

s.inoue@uwajima-mh.jp


Sponsor or person

Institute

Uwajima City Hospital

Institute

Department

Personal name



Funding Source

Organization

None

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



Secondary IDs

Secondary IDs

NO

Study ID_1


Org. issuing International ID_1


Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions



Other administrative information

Date of disclosure of the study information

2016 Year 12 Month 01 Day


Related information

URL releasing protocol


Publication of results

Unpublished


Result

URL related to results and publications


Number of participants that the trial has enrolled


Results


Results date posted


Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics


Participant flow


Adverse events


Outcome measures


Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2016 Year 12 Month 01 Day

Date of IRB


Anticipated trial start date

2016 Year 12 Month 01 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2016 Year 12 Month 01 Day

Last modified on

2018 Year 06 Month 07 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028864


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name